All Employees of Premier Medical Group are required to demonstrate our core values of Integrity, Respect and Compassion throughout their employment with us, placing patients first. Our employees must commit to always acknowledging our patients positively; showing genuine concern for their needs, identifying themselves and how they and others on the team can help, keeping patients informed and offering thanks for choosing and trusting us with their healthcare needs.

Job Purpose: Coordinates and administers research study associated activities. Assists in project planning, and ensures that pre-established work scope, study protocol, and regulatory requirements are followed. Recruits and coordinates research subjects, performs research study visits, maintains study documentation, data, study medication and works directly with the Director of Clinical Research and Principle Investigator to ensure protocol adherence and patient clinical care are provided to each study patient.

Essential Functions

1. Understand the given study protocol and aspects of implementing the protocol.
2. Assist the PI in training all key research personnel in understanding and implementing to study protocol.
3. Assist the PI in recruiting and screening potential research study patients.
4. Review EMR and patient medical history and medication lists to ensure adherence to the specific inclusion/exclusion criteria in the IRB approved protocol.
5. Review and understand the current approved study specific Informed Consent Form (ICF) to ensure it has been IRB approved and provides adequate information to the patient including what is required for the patient, their risk in study participation, who can access their information, how they can withdraw, whom they should contact and that the PHI is explained.
6. Assist the PI in performing the consenting process and helps to ensure the consent process occurs following the GCP guidelines and Premier Medical Group’s SOPs such that the patient is allowed to ask questions and given time to review the ICF prior to signing.
7. Assist the PI in assuring amended consent forms are appropriately implemented and signed.
8. Schedule and coordinate participant visits and ensure that all appropriate study procedures are completed and documented.
9. Collect patient vitals such as weight, height, blood pressure, pulse, ECG, etc.
10. Collect data as required by the protocol and complete case report forms as well as address any queries on data.
11. Collect all required lab data and other procedures for the PI to review and sign off on.
12. Collect any adverse events or unexpected outcomes to the PI.
13. Assist the PI and research team in reporting any unexpected events, protocol deviations, violations, incidents or patient complaints.
14. Dispense, review and collect patient study medication.
15. Maintain study files in accordance with sponsor, IRB and Premier Medical Group requirements.
16. Maintain effective and ongoing communication with the PI, Director of Clinical Research, sponsor research team, and research participants during the course of the study.
17. Help schedule and facilitate sponsor monitoring visits, and any audits that may occur.
18. Work with the PI and research team to manage the day-to-day activities of the study including problem solving, protocol management and patient care.
19. Performs other duties as assigned.
20. Maintains confidentiality.

Education: High school diploma or equivalent; graduation from an accredited medical assisting or nursing program preferred.

Experience: Minimum of 1 year clinical experience in an outpatient medical office using an EHR, preferred.

Knowledge and Skills: Knowledge of examination, diagnostic and treatment room procedures. Knowledge of common safety hazards and precautions to maintain a safe work environment.

Skill in taking vital signs. Skill in maintaining records and recording test results. Skill in establishing and maintaining effective working relationships with patients, staff and the public.

Ability to maintain quality control standards. Ability to react calmly and effectively in emergency situations. Ability to read, understand and respond to detailed oral and written instructions. Ability to communicate clearly.

Licenses/Certifications: Valid state nursing license, if applicable. CPR certification.